The Week Ahead In Biotech (Sept. 12-18): Calliditas FDA Decision, Adcom Review For Pfizer/BioNTech COVID-19 Vaccine, Oncology Conference And IPOs
Biotech stocks retreated in the holiday-shortened week ending Sept. 10, reversing course from the previous week.
Humanigen, Inc. (NASDAQ: HGEN) was among the biggest decliners of the week after the company said the Food and Drug Administration refused to authorize its COVID-19 treatment for emergency use. Mersana Therapeutics, Inc. (MRSN) and Apellis Pharmaceuticals, Inc. (APLS) pulled back notably in reaction to clinical trial disappointments.
On the other hand, Surrozen, Inc. (NASDAQ: SRZN), which went public via a SPAC deal, advanced notably. Stifel initiated coverage of the stock with a Buy rating and $19 price target.
In a big-ticket M&A announcement, Kadmon Holdings, Inc. (NASDAQ: KDMN) struck a deal to be acquired by French pharma giant Sanofi (NASDAQ: SNY) for $1.9 billion in cash.
Here are the key catalytic events scheduled for the unfolding week:
Conferences
International Association for the Study of Lung Cancer, or IASLC, 2021 World Conference On Lung Cancer: Sept 8-14 (virtual event)
Morgan Stanley 19th Annual Global Healthcare Conference: Sept. 9-15 (virtual event)
BofA Global Healthcare Conference 2021: Sept. 15-16 (virtual event)
European Society for Medical Oncology 2021 Congress: Sept. 16-21 (virtual event)
International Workshop On CLL, or iwCLL: Sept. 17-20 (virtual event)
PDUFA Dates
The FDA is scheduled to rule on Calliditas Therapeutics AB (NASDAQ: CALT)’s new drug application for Nefecon in IgA nephropathy by the PDUFA action date of Wednesday, Sept. 15.
Biogen Inc. (NASDAQ: BIIB) and Samsung Bioepis await FDA’s verdict on their Biologic license application for SB11, a biosimilar to Roche Holding AG (OTC: RHHBY)’s Lucentis, which is indicated for a slew of retinal vascular disorders. The decision is likely to be announced by Friday, Sept. 17, estimated based on the 10-month standard review period from the date of filing.
Adcom Calendar
FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet on Friday, Sept. 17, between 8:30 am and 3:45 pm, to discuss Pfizer, Inc. (NYSE: PFE)/BioNTech SE (NASDAQ: BNTX)’s COVID-19 vaccine, Comirnaty, for administration of a third dose, or “booster” dose in individuals 16 years of age and older.
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Clinical Readouts/Presentations
Standalone Releases
Hepion Pharmaceuticals, Inc. (NASDAQ: HEPA) is scheduled to release additional data from its Phase 2a ‘AMBITION’ NASH clinical trial of CRV431 before the market opens Monday, Sept. 13,
IASLC World Lung Conference Presentations
Coherus BioSciences, Inc. (NASDAQ: CHRS) will make a mini-oral presentation of CHOICE-01 Phase 3 study of toripalimab versus placebo in combination with first-line chemotherapy for advanced non-small cell lung cancer. The presentation is scheduled for Monday, Sept. 13 at 8:10 pm.
ESMO Presentations
Among the companies due to present at ESMO 2021 include:
Merck & Company, Inc. (NYSE: MRK): new Phase 3 results for Keytruda in melanoma and in recurrent, persistent or metastatic cervical cancer
AstraZeneca PLC (NASDAQ: AZN): interim results from the ORCHARD Phase 2 trial studying the combination of Tagrisso and savolitinib in patients with advanced EGFR-mutated non-small cell lung cancer, with MET alterations whose disease progressed on 1st-line Tagrisso; results from the DESTINY-Breast03 Phase 3 trial of Enhertu for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane
MacroGenics, Inc. (NASDAQ: MGNX): interim safety and efficacy data from Phase 2/3 MAHOGANY study of margetuximab in combination with retifanlimab in advanced gastric and gastroesophageal junction cancer.
Gritstone bio, Inc. (NASDAQ: GRTS): GRANITE Phase 1/2 data in advanced solid tumors and data from the SLATE v1 shared neoantigen immunotherapy program in KRAS mutant advanced solid tumors
Aileron Therapeutics, Inc. (NASDAQ: ALRN): preliminary data from its Phase 1 study of ALRN-6924 in healthy volunteers and final data from its completed Phase 1b study of ALRN-6924 in patients with small cell lung cancer receiving second-line topotecan treatment.
Coherus BioSciences: interim results of the JUPITER-06 Phase 3 Study of Toripalimab versus placebo in combination with first-Line Chemotherapy for treatment-naive advanced or metastatic esophageal squamous cell carcinoma
Corcept Therapeutics Incorporated (NASDAQ: CORT): results from the Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer
iwCLL Presentations
TG Therapeutics, Inc. (NASDAQ: TGTX) will present data from the Phase 1/2 study of umbralisib + ublituximab + Merck’s Keytruda in patients with relapsed/refractory chronic lymphocytic leukemia and Richter’s transformation.
Earnings
MaxCyte, Inc. (NASDAQ: MXCT) (Monday, after the close)
IPOs
Redwood, California-based Procept Biorobotics Corporation (NASDAQ: PRCT) has filed with the SEC a preliminary prospectus for offering 5.5 million shares in an initial public offering to be priced between $22 and $24. Procept Biorobotics, a commercial-stage surgical robotics company, expects to list its shares on the Nasdaq under the ticker symbol PRCT.
Tyra Biosciences Inc. (NASDAQ: TYRA), a Carlsbad, California-based precision-oncology company, is proposing to offer 6.7 million shares in an IPO. The company expects to price the offering between $14 and $16, and intends to list its shares on the Nasdaq under the ticker symbol TYRA.
Dice Therapeutics, Inc. (NASDAQ: DICE) is planning to offer 10 million shares in an IPO, with the pricing estimated to be in the range of $15-$17. The South San Francisco, California-based company is a biopharma, leveraging its proprietary technology platform to build a pipeline of oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas.
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