The Week Ahead In Biotech (Oct. 3-9): ChemoCentryx FDA Decision, Conference Presentations, IPOs And More

Biotech stocks came under pressure in the week ending Oct. 1, dragged by broader market weakness and the selling of vaccine stocks.

Positive tidings from Merck & Co., Inc. MRK regarding its COVID-19 treatment candidate sent vaccine stocks tumbling Friday. Data from a late-stage study showed that molnupiravir, which Merck co-develops with Ridgeback Biotherapeutics, reduces hospitalization risk or death by approximately 50% in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19.

Merck was also in the headlines this week after it confirmed speculation regarding its acquisition of Acceleron Pharma Inc. XLRN for $11.5 billion, as it strives to cushion any downside from a potential slowdown in the sales of its blockbuster cancer immunotherapy Keytruda.

Omeros Corporation OMER was among the biggest decliners of the week after the company disclosed that the FDA identified deficiencies in its biologic license application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Here are the key catalysts that could move stocks in the unfolding week:

Conferences

American Society for Bone and Mineral Research, or ASBMR, 2021 Annual Meeting (hybrid): Oct. 1-4 (San Diego, California)

2021 Annual Northeast Amyotrophic Lateral Sclerosis, or NEALS, Meeting (virtual): Oct. 6-7

Chardan's 5th Annual Genetic Medicines Conference (virtual): Oct. 5-6

Goldman Sachs Small/Mid-Cap Healthcare Day (virtual): Oct. 7

AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics: Oct. 7-10

American Society of Retina Specialists, or ASRS, 2021 Annual Meeting: Oct. 8-12 (San Antonio, Texas)

PDUFA Dates

The Food and Drug Administration is scheduled to rule on ChemoCentryx, Inc. CCXI's new drug application for avacopan as a treatment for ANCA-associated vasculitis. After a split Adcom verdict, the FDA had extended the review period by three months, thereby pushing forward the PDUFA date.

ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This leads to organ damage and failure, mainly the kidney, and is fatal if not treated.

Adcom Calendar

FDA's Antimicrobial Drugs Advisory Committee will discuss Takeda Pharmaceutical Company Limited TAK's NDA for maribavir oral tablets for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant. The meeting is scheduled to be held Thursday, Oct. 7, between 9 a.m. and 5 p.m.

Clinical Readouts

ASBMR Presentation

Ascendis Pharma A/S ASND: Phase 2, week 58 data from the PaTH Forward trial of TransConPTH, an investigational hormone replacement therapy for adult patients with hypoparathyroidism (Monday, 2:30 pm to 3:45 pm)

NEALS Meeting Presentation

Denali Therapeutics Inc. DNLI: data from the Phase 2, study, followed by an open-label long-term extension, to evaluate the efficacy and aafety of SAR443820 in adult participants with amyotrophic lateral sclerosis (Wednesday, 4 pm to 5 pm)

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

AACR-NCI-EORTC Conference Presentations

Prelude Therapeutics Incorporated PRLD: data from the dose escalation portion of the Phase 1 trial of PRT543 in unselected solid tumor patient populations; data from the dose escalation portion of the Phase 1 trial of PRT811 in solid tumors and high-grade gliomas

Turning Point Therapeutics, Inc. TPTX: Update from the Phase 2 registrational trial of repotrectinib in TKI-pretreated patients with ROS1+ advanced non-small cell lung cancer and with NTRK+ advanced solid tumors (Thursday, 9 am)

Bicycle Therapeutics plc BCYC: data from Phase 1/2 study of BT5528 in patients with advanced malignancies associated with EphA2 expression (Thursday, 12:50 pm)

Turning Point & Zai Lab Limited ZLAB: Preliminary interim Phase 1 data of elzovantinib (TPX-0022) in patients with advanced solid tumors harboring genetic alterations in MET (Thursday, 9 am)

Forma Therapeutics Holdings, Inc. FMTX: initial results from the Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer

ORIC Pharmaceuticals, Inc. ORIC: initial results from the Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with Pfizer, Inc. PFE's Xtandi in patients with metastatic prostate cancer (Thursday, 9 am)

Relay Therapeutics, Inc. RLAY: initial results of RLY-4008 in patients with FGFR2-altered cholangiocarcinoma and multiple solid tumors (Friday, 10:25 am)

Repare Therapeutics Inc. RPTX: data from the Phase I TRESR trial of RP-3500 in patients with advanced solid tumors harboring synthetic lethal genomic alterations (Friday, 3:15 pm)

ASRS Meeting Presentations

Adverum Biotechnologies, Inc. ADVM: Phase 2 data for intravitreal gene therapy for diabetic macular edema with ADVM-022 (Saturday, 11:28 am)

REGENXBIO Inc. RGNX & Clearside Biomedical, Inc. CLSD: initial data from the Phase 2 AAVIATE trial of RGX-314 for the treatment of wet age-related macular degeneration (Saturday)

Earnings

Enzo Biochem, Inc. ENZ (Tuesday, before the market open)
Theratechnologies Inc. THTX (Wednesday, before the market open)

IPOs

IPO Pricing

Branford, Connecticut-based IsoPlexis Corporation ISO has filed a preliminary prospectus with the SEC for offering 8.333 million shares in an initial public offering. The company expects to price the offering between $14 and $16 and list the shares on the Nasdaq under the ticker symbol "ISO."

The company's single cell proteomics platform has been adopted by the top global biopharmaceutical companies and comprehensive cancer centers in the U.S. to help develop more durable therapeutics, overcome therapeutic resistance, and predict patient responses for advanced immunotherapies, cell therapies, gene therapies, vaccines, and regenerative medicines.

Cingulate Inc CING, a clinical stage biopharma using its proprietary "Precision Timed Release" drug delivery platform technology, has filed for offering 4.55 million shares in an IPO at an estimated price range of $10-$12. The Kansas-based company has applied for listing its shares on the Nasdaq under the ticker symbol "CING."

Theseus Pharmaceuticals, Inc. THRX proposes to offer in an IPO, 8.3335 million shares of its common stock, which it expects to price between $14 and $16. The Cambridge, Massachusetts-based biopharma is engaged in the development of targeted cancer therapies. It has applied for listing its shares on the Nasdaq under the ticker symbol "THRX."

Related Link: Aduhelm's 'Blockbuster Potential' Is Underappreciated, Says Biogen Analyst