The Week Ahead In Biotech: Decision Day For Bausch Health, IPO Flow Resumes, Oncology Conference

Biotech stocks continued to remain under pressure in the week ended Sept. 11, swayed by the volatility that was evident in the broader market.

The week also witnessed a flurry of news flow on the coronavirus vaccine front. Even as nine vaccine makers released a pledge to put safety first, AstraZeneca plc AZN was forced to voluntarily stall the late-stage study of its coronavirus vaccine, citing an unidentified illness in one of the trial participants. Clinical trials were allowed to resume on Sept. 12.

Still, clinical trial readouts led to wild swings in some stocks.

Here are the key catalysts for the unfolding week:

Conferences:

• The International Parkinson and Movement Disorder Society, or MDS, Virtual Congress 2020: Sept. 12–16.
• H.C. Wainwright Virtual Healthcare Conference: Sept. 14-16
• 2nd RAS- Targeted Drug Development Summit 2020: Sept. 14-16
• 18th Annual Morgan Stanley Healthcare Conference: Sept. 14-18
• 2020 Cantor Global Virtual Healthcare Conference: Sept. 15-17
• European Society for Medical Oncology, or ESMO, Virtual Congress 2020: Sept. 14-21

PDUFA Dates

The FDA is set to rule on Bausch Health Companies Inc.'s BHC NDA for EM-100, a ketotifen preservative-free ophthalmic solution that is being evaluated for allergic conjunctivitis. Bausch had in-licensed EM-100 from Eton Pharmaceuticals Inc. ETON in Feb. 2019. The PDUFA date is set for Tuesday.

Clinical Trial Readouts/Presentations

Prothena Corporation PLC PRTA: results from Part 1 of the Phase 2 PASADENA study of prasinezumab in early Parkinson's disease (Tuesday)

2nd RAS- Targeted Drug Development Summit Presentations

Verastem Inc VSTM: updated data from the LGSOC cohort of the Phase 1/2 FRAME study evaluating VS-6766 and defactinib in KRAS mutant solid tumors, and new preclinical data from studies investigating VS-6766 and defactinib in combination with KRAS-G12C inhibitors (Wednesday)

See also: AstraZeneca's Coronavirus Vaccine Setback 'Mixed Blessing' For Moderna: Analyst

ESMO Congress Presentations

IMMUTEP LTD/S ADR IMMP: initial results from a Phase 2 study of eftilagimod alpha and Keytruda as 2nd line treatment for PD-L1 unselected metastatic head and neck cancer patients and non-small cell lung cancer, or NSCLC, patients, and safety data from stratum D of the phase 1 trial evaluating feasibility of IMP321 combined with avelumab in advanced stage solid tumor (Thursday)

Clovis Oncology Inc CLVS: initial data from the Phase 1b part of the LIO-1 trial of lucitanib in combination with Opdivo in advanced metastatic solid tumors, new data analyses for Rubraca from the Phase 2 TRITON2 and Phase 3 ARIEL3 studies in patients with metastatic castration-resistant prostate cancer and recurrent ovarian cancer, respectively, and preclinical data for FAP-2286 in a variety of cancers

Mersana Therapeutics Inc MRSN: updated interim data from the ovarian cancer cohort of the ongoing Phase 1 expansion study evaluating XMT-1536 (Thursday)

Alkermes Plc ALKS: Safety and anti-tumor efficacy data from the phase 1/2 ARTISTRY-1 study, evaluating ALKS 4230 as monotherapy and in combination with Keytruda in patients with refractory solid tumors (Friday)

Ayala Pharmaceuticals Inc AYLA: interim results from the Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma harbouring Notch activating mutations (Friday)

Agenus Inc AGEN: data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab (Friday)

Autolus Therapeutics PLC AUTL: Phase 1/2 data for AUTO3, its CAR T cell therapy being investigated in relapsed/ refractory diffuse large B cell lymphoma (Friday)

Arcus Biosciences Inc RCUS: efficacy and safety data from a Phase 1/1b study of etrumadenant plus carboplatin, pemetrexed and anti-PD-1 therapy in patients with metastatic NSCLC

Beigene Ltd BGNE: data from the Phase 3 trial of tislelizumab combined with chemotherapy for the first-line treatment of patients with advanced non-squamous NSCLC, and data from the Phase 1/2 trial of pamiparib in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer

Deciphera Pharmaceuticals Inc DCPH: data from Part 2 of the ovarian cancer cohort of the Phase 1b/2 study in combination with paclitaxel, and updated data from the phase 3 INVICTUS study of ripretinib as fourth-line and above treatment in patients with advanced gastrointestinal stromal tumors

NuCana PLC NCNA: Phase 1b data for NUC-3373 in colorectal cancer and Phase 1 study of NUC-7738 in advanced solid tumors

Immunomedics, Inc. IMMU: data from a phase 3 study of sacituzumab govitecan versus treatment of physician's choice in patients with previously treated metastatic triple-negative breast cancer and final results from a Phase 2 study of sacituzumab govitecan in metastatic urothelial cancer (Saturday)

ImmunoGen Inc. IMGN: mature data from the triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin in patients with recurrent, platinum-sensitive ovarian cancer

MacroGenics Inc MGNX: data from the Phase 1 dose escalation study of MGD019 in solid tumors

Veru Inc VERU: results from Phase 1b/2 study of VERU-111 in castration-resistant prostate cancer

Fortress Biotech FBIO and Checkpoint Therapeutics Inc CKPT: updated interim safety and efficacy data for cosibelimab in cutaneous squamous cell carcinoma

Earnings

Champions Oncology Inc CSBR (Monday, after the close)

IPOs

Waltham, Massachusetts-based Dyne Therapeutics, Inc. has filed to offer 10.30 million shares in an initial public offering, or IPO, at an estimated price range of $16-$18. The muscle disease company focused on therapeutics for patients with genetically driven diseases has applied for listing its shares on the Nasdaq under the ticker symbol DYN

Metacrine, Inc., a clinical-stage biopharmaceutical company focused on developing differentiated therapies for patients with liver and gastrointestinal diseases, is proposing to offer 6.54 million shares in an IPO. The company expects to price the offering between $12 and $14. The San Diego, California-based company has applied for listing its shares on the Nasdaq under the ticker symbol MTCR.

San Jose, California-based Outset Medical, Inc. is planning a 7.6-million IPO, to be priced between $22 and $24. The medical technology company expects to list its shares on the Nasdaq under the ticker symbol OM.

IPO Quiet Period Expiry

Harmony Biosciences Holdings Inc HRMY
Inhibrx Inc INBX
Nano-X Imaging Ltd NNOX
Kymera Therapeutics Inc KYMR

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