On February 11, 2020 Fortress Biotech, Inc. (Common Stock: Nasdaq: FBIO) (Preferred Stock: Nasdaq: FBIOP) ("Fortress"), an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, reported that it has priced an underwritten public offering of 625,000 shares of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock at a price of $20 per share, with expected gross proceeds to Fortress of $12.5 million (Press release, Fortress Biotech, FEB 11, 2020, View Source [SID1234554221]). In addition, Fortress has granted the underwriters a 45-day option to purchase up to 93,750 additional shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about February 14, 2020, subject to customary closing conditions.

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The Benchmark Company, LLC and ThinkEquity, a division of Fordham Financial Management, Inc. are acting as joint bookrunning managers for the offering.

Fortress intends to use the net proceeds from the public offering for its operations, including, but not limited to, general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

The offering is being made by Fortress pursuant to an effective shelf registration statement on Form S-3 (File 333-226089) previously filed with the Securities Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and related prospectus supplement that form a part of the registration statement. A copy of the final prospectus supplement and accompanying prospectus related to this offering may be obtained from any of the underwriters, including the offices of The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: [email protected], and the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected]. You may also obtain these documents for free when they are available by visiting the SEC’s website at www.sec.gov.

On February 11, 2020 Immune Therapeutics, Inc. (OTC Pink: IMUN) ("Immune" "IMUN" or the "Company"), a clinical late stage biopharmaceutical company focused on the development of therapies for the treatment of autoimmune diseases, inflammatory diseases reported an update on the pending 1000 to 1 reverse stock split and name change of Immune Therapeutics (Press release, Immune Therapeutics, FEB 11, 2020, View Source [SID1234554149]).

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Immune Therapeutics originally submitted the reverse and name request for a corporate action to FINRA and paid the applicable fees on November 27, 2019. Since then, the company has responded to FINRA’s requests for further information multiple times, and we continue in our efforts to work diligently and cooperatively with FINRA to process the reverse and name change. Please note that the Company has no control of the FINRA approval process and as such the timing of any decisions our not in the Company’s control.

Michael K. Handley, CEO of Immune, said, "We are disappointed in the delay in processing the reverse and name change and remain fully committed to the restructuring and success of IMUN. I would personally like to thank all of our shareholders for their patience in this process. We realize this delay has eroded share value, and confidence however, based on the extensive review by FINRA, we are optimistic that their approval could be given soon, at which time we will certainly inform shareholders immediately. Immune would like to thank our shareholders for standing behind us, as we continue to work in your interests with a commitment to the reverse and merger with Aletheia as soon as possible."

On February 11, 2020 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for capmatinib, an investigational, selective MET inhibitor, as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC) (Press release, Incyte, FEB 11, 2020, View Source [SID1234554166]). If approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis2,3.

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There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC. NSCLC accounts for approximately 85% of lung cancer diagnoses4. METex14 mutations occur in 3-4% of newly-diagnosed advanced NSCLC cases5 and is a recognized oncogenic driver6,7.

"Patients with METex14 mutated advanced NSCLC, an aggressive form of the disease, often face a poor prognosis due to lack of available treatment options," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We are pleased the FDA has accepted the NDA for capmatinib for Priority Review – a critical step toward providing the first METex14 mutation targeted therapy to this subset of lung cancer patients."

The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to 10 months for Standard Review. Capmatinib was previously granted Breakthrough Therapy designation by the FDA.

The NDA submission for capmatinib was supported by results from the Novartis-sponsored GEOMETRY mono-1 Phase 2 study, which demonstrated overall response rates of 67.9% (95% CI, 47.6 – 84.1)1 and 40.6% (95% CI, 28.9–53.1)1 among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The study also demonstrated that capmatinib provided durable responses among all patients: median duration of response was 11.14 months (95% CI, 5.55 – NE) in treatment-naïve patients and 9.72 months (95% CI, 5.55 – 12.98) in previously treated patients1.

All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response1. The most common treatment-related adverse events (AE) (≥ 10% all grades) across all cohorts (N=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%). The majority of the AEs were grades 1/21.

About GEOMETRY mono-1

The Novartis-sponsored GEOMETRY mono-1 trial is an international, prospective, multi-cohort, non-randomized, open-label Phase 2 study to evaluate the efficacy and safety of single-agent capmatinib in adult patients with EGFR wildtype, ALK-negative rearrangement, advanced NSCLC harboring a MET amplification and/or mutation. Patients with locally advanced or metastatic NSCLC harboring a MET exon-14 skipping mutation (centrally confirmed) were assigned to Cohorts 4 (previously treated patients) or 5B (treatment-naïve), regardless of MET amplification/gene copy number and received 400 mg capmatinib tablets orally twice daily. The primary endpoint was ORR based on BIRC assessment per RECIST v1.1. The key secondary endpoint was DOR by BIRC.

About Capmatinib

Capmatinib (INC280) is an investigational, oral and selective MET inhibitor discovered by Incyte and licensed to Novartis in 2009. Under the terms of the Agreement, Incyte granted Novartis exclusive worldwide development and commercialization rights to capmatinib and certain back-up compounds in all indications. If capmatinib is successfully developed by Novartis, Incyte may become eligible for over $500 million in future milestones as well as royalties of between 12 and 14 percent on global sales by Novartis.

On February 11, 2020 Penumbra, Inc. (NYSE: PEN) reported that it will host a conference call to discuss financial results for the fourth quarter and full year 2019 after market close on Tuesday, February 25, 2020 at 5:00 PM Eastern Time (Press release, Penumbra, FEB 11, 2020, View Source [SID1234554183]). A press release with fourth quarter and full year 2019 financial results will be issued after market close that day.

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Webcast & Conference Call Information
The conference call can be accessed live over the phone by dialing (833) 227-5837 for domestic callers or (647) 689-4064 for international callers (conference id: 3899277), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

On February 11, 2020 Novartis reported that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA) (Press release, Novartis, FEB 11, 2020, View Source [SID1234554129]). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC). If approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis2,3.

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Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to ten months under Standard Review. Novartis was previously granted Breakthrough Therapy designation for capmatinib.

There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC. NSCLC accounts for approximately 85% of lung cancer diagnoses4. METex14 mutations occur in 3-4% of newly diagnosed advanced NSCLC cases5 and is a recognized oncogenic driver6,7. As part of the continued collaboration between Novartis and Foundation Medicine, Inc., companion diagnostics for capmatinib are in development for both tumor tissue and liquid biopsies to be included on FoundationOneCDx* and the forthcoming version of Foundation Medicine’s liquid biopsy platform, which is currently under review with the FDA. Foundation Medicine is a leading provider of comprehensive genomic profiling solutions for patients with advanced cancer, including NSCLC.

"We are extremely encouraged by the FDA’s Priority Review designation for capmatinib, a MET inhibitor that may be a major treatment advance for patients with this particularly aggressive form of lung cancer," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis. "Results of the GEOMETRY mono-1 trial clearly identify METex14 as an oncogenic driver and we are inspired to bring capmatinib, potentially the first METex14 targeted therapy, to patients and to reimagine medicine and outcomes for people with lung cancer."

The NDA submission for capmatinib is supported by results from the GEOMETRY mono-1 Phase II study, which demonstrated an overall response rate of 67.9% (95% CI, 47.6 – 84.1)1 and 40.6% (95% CI, 28.9 – 53.1)1 among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The study also demonstrated that capmatinib provided durable responses among all patients: median duration of response was 11.14 months (95% CI, 5.55 – NE) in treatment-naïve patients and 9.72 months (95% CI, 5.55 – 12.98) in previously treated patients1.

All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response1. The most common treatment-related adverse events (AE) (≥ 10% all grades) across all cohorts (N=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%). The majority of the AEs were grades 1/21.

About Lung Cancer
Lung cancer is the most common cancer worldwide, accounting for 2.1 million new cases and 1.8 million deaths in 20188. There are two main types of lung cancer – small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)9. NSCLC accounts for approximately 85% of lung cancer diagnoses, inclusive of known oncogenic mutations4. The MET exon 14 skipping mutation occurs in 3-4% of newly diagnosed advanced NSCLC cases5. There are currently no approved therapies specifically targeted to treat METex14 mutated advanced lung cancer.

About Capmatinib
Capmatinib (INC280) is an investigational, oral, potent and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.