Biotech stocks continued to remain under pressure in the week ended September 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 September 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: September 12–16.
• H.C. Wainwright Virtual Healthcare Conference: September 14-16.
• 2nd RAS- Targeted Drug Development Summit 2020: September 14-16.
• 18th Annual Morgan Stanley Healthcare Conference: September 14-18.
• 2020 Cantor Global Virtual Healthcare Conference: September 15-17.
• European Society for Medical Oncology, or ESMO, Virtual Congress 2020: September 14-21.

PDUFA Dates

The FDA is set to rule on Bausch Health Companies Inc.(BHC)'s 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 February of 2019. The PDUFA date is set for Tuesday, September 15.

Clinical Trial Readouts/Presentations

Prothena Corporation PLC (PRTA): Presenting results from Part 1 of the Phase 2 PASADENA study of prasinezumab in early Parkinson's disease on Tuesday, September 15.

2nd RAS- Targeted Drug Development Summit Presentations

Verastem Inc. (VSTM): Presenting 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 on Wednesday, September 16.

ESMO Congress Presentations

• IMMUTEP LTD/S ADR (IMMP): Presenting 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, patients, and safety data from stratum D of the phase 1 trial evaluating feasibility of IMP321 combined with avelumab in advanced stage solid tumor. This is scheduled for Thursday, September 17.
• Clovis Oncology Inc. (CLVS): Presenting 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): Presenting updated interim data from the ovarian cancer cohort of the ongoing Phase 1 expansion study evaluating XMT-1536 on Thursday, September 17.
• Alkermes Plc. (ALKS): Presenting 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 on Friday, September 18.
• Ayala Pharmaceuticals Inc. (AYLA): Presenting interim results from the Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma harbouring Notch activating mutations on Friday, September 18.
• Agenus Inc. (AGEN): Presenting data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab on Friday, September 18.
• Autolus Therapeutics PLC. (AUTL): Presenting Phase 1/2 data for AUTO3, its CAR T cell therapy being investigated in relapsed/ refractory diffuse large B cell lymphoma on Friday, September 18.
• Arcus Biosciences Inc. (RCUS): Presenting 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): Presenting 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): Presenting 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): Presenting Phase 1b data for NUC-3373 in colorectal cancer and Phase 1 study of NUC-7738 in advanced solid tumors.
• Immunomedics, Inc. (IMMU): Presenting 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 on Saturday, September 19.
• ImmunoGen Inc. (IMGN): Presenting 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): Presenting data from the Phase 1 dose escalation study of MGD019 in solid tumors.
• Veru Inc. (VERU): Presenting results from Phase 1b/2 study of VERU-111 in castration-resistant prostate cancer.
• Fortress Biotech (FBIO) and Checkpoint Therapeutics Inc. (CKPT): Presenting 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).