Biotech stocks reversed course last week, dragged lower by the broader market weakness. The week's news flow was headlined by Johnson & Johnson (JNJ) kickstarting a Phase 3 trial of its coronavirus vaccine candidate.

A few clinical readouts released during the week triggered strong moves. Vaccinex Inc. (VCNX) and AC Immune SA (ACIU) were among the worst decliners of the week, with the former reacting to a failed mid-stage trial of lead drug in Huntington's disease, while the latter plunged after an out-licensed Alzheimer's drug flunked a mid-stage trial.

Here are the key catalysts for the unfolding week.

Conferences

• World Muscle Society, or WMS, 25: Virtual Congress: September 28 - October 2.
• Annual Northeast Amyotrophic Lateral Sclerosis, or NEALS, meeting: September 30 - October 1.
• Heart Failure Society of America, or HFSA, Virtual Annual Scientific Meeting 2020: September 30 - October 6.
• virtual Jefferies Cell Therapy Summit: October 5-6.
• Virtual Jefferies Gene Therapy/Editing Summit: October 1-2.
• North American Neuroendocrine Tumor Society, or NANETS', Multidisciplinary NET Medical Virtual Symposium: October 2-3.
• Virtual 7th Immunotherapy of Cancer Conference, or ITOC7: October 2-3.
• EURETINA 2020 Virtual Meeting: October 2-4.

PDUFA Dates

• The FDA is set to rule on Aquestive Therapeutics Inc. (AQST)'s NDA for libervant (AQST-203) in seizure clusters on Sunday, October 4.
• The regulatory agency is also scheduled on Tuesday, September 29 to give its verdict on Eton Pharmaceuticals Inc. (ETON)'s NDA for Alkindi Sprinkle, which is being evaluated as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age.
• Mesoblast limited (MESO) awaits FDA decision on Wednesday, September 30 on its BLA for remestemcel-L (MSC-100-IV) in steroid-refractory acute graft versus host disease in children.
• Roche Holdings AG's Basel (RHHBY) regulatory application seeking label expansion for Xolair to be used for chronic rhinosinusitis with nasal polyps has a PDUFA timeline of Q3

Clinical Readouts

• Capricor Therapeutics Inc. (CAPR) is scheduled Thursday, October 1 to present at the WMS Congress novel data from its Phase 2 HOPE-2 clinical trial of lead asset CAP-1002, in boys and young men with Duchenne muscular dystrophy.
• Xencor Inc. (XNCR) will present Friday, October 2 at the NANETS symposium initial data from its Phase 1 dose-escalation study of tidutamab in patients with neuroendocrine tumors.
• Spring Bank Pharmaceuticals Inc. (SBPH) is due to present at the ITOC7, Phase 1a/1b data for intravenous SB 11285 in solid tumors.
• MeiraGTx Holdings PLC (MGTX) will present at the EURETINA meeting Saturday, October 3, discussing nine-month results from the ongoing Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy for the treatment of X-linked retinitis pigmentosa.
• At the EURETINA meeting on Saturday, October 3, Apellis Pharmaceuticals Inc. (APLS) will make a late-breaker oral presentation of post hoc analysis of the Phase 2 FILLY study investigating intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration.
• Cytokinetics, Inc. (CYTK) is due to present at the HFSA meeting new data from the Phase 3 event regarding the clinical trial of omecamtiv mecarbil and additional results thee completed Phase 2 clinical trial, which evaluated omecamtiv mecarbil in patients with heart failure with reduced ejection fraction.

Q3 Releases

• Ovid Therapeutics Inc. (OVID): results from the Phase 2 ARCADE trial in CDKL5 deficiency disorder and Dup15q syndrome, results from Phase 2 ELEKTRA trial in patients with Dravet syndrome and Lennox-Gastaut syndrome, and updated data from the ENDYMION open-label extension study in developmental and epileptic encephalopathies.
• Selecta Biosciences Inc. (SELB): topline data from the head-to-head COMPARE trial of once-monthly dose of SEL-212 (ImmTOR + pegadricase) compared to biweekly doses of pegloticase in tophaceous gout.
• Synthetic Biologics Inc. (SYN): interim futility analysis of Phase 2b investigator-sponsored clinical trial of SYN-010, intended to treat irritable bowel syndrome-constipation.
• Cyclerion Therapeutics Inc. (CYCN): top-line results from the Phase 2 STRONG-SCD study of olinciguat, in sickle cell disease (late Q3).
• Atara Biotherapeutics Inc. (ATRA): interim analysis of the tab-cel Phase 3 study in Epstein-Barr virus and post-transplant lymphoproliferative disease after solid organ transplant.
• Alnylam Pharmaceuticals, Inc. (ALNY): topline results from the ILLUMINATE-B Phase 3 study of lumasiran in primary hyperoxaluria type 1 patients less than six years of age with preserved renal function.
• Momenta Pharmaceuticals, Inc. (MNTA): results from Part B of the Phase 1/2 study of M254 in idiopathic thrombocytopenic purpura.
• Myovant Sciences Ltd. (MYOV): Castration-resistance free survival data for relugolix in prostate cancer.
• Ascendis Pharma A/S (ASND): six-month data from the open-label extension portion of the PaTH Forward Trial evaluating TransCon for hypoparathyroidism.
• Corbus Pharmaceuticals Holdings Inc. (CRBP): topline results from the Phase 2b study of lenabasum for cystic fibrosis.
• Aerie Pharmaceuticals Inc. (AERI): Mercury 3 topline readout, highlighting Roclanda's intraocular pressure reducing performance compared to Ganfort.
• BioCryst Pharmaceuticals, Inc. (BCRX): Part 1 of galidesivir trial in COVID-19 patients (end of Q3) and data from the Phase 1 study of BCX9930 in treatment-naïve Paroxysmal nocturnal hemoglobinuria in patients.

September Releases

Tonix Pharmaceuticals Holding Corp. (TNXP): interim analysis of results for Phase 3 RELIEF trial of TNX-102 SL for the management of Fibromyalgia.

Coronavirus Vaccine Updates

• Moderna Inc. (MRNA): interim Phase 2 efficacy data of RNA-m1273 (Q3).
• Inovio Pharmaceuticals Inc. (INO): commencement of Phase 2/3 study of INO-4800 DNA vaccine candidate in September.
• Regeneron Pharmaceuticals Inc. (REGN): initial virology and biomarker data in September of Phase 2/3 trial REGN-COV2, an antiviral antibody, in COVID-19.

Earnings

AngioDynamics, Inc. (ANGO) reports earnings on Tuesday, September 29 before the market open.

IPOs

Exton, Pennsylvania-based Immunome, Inc. has filed with the SEC a preliminary prospectus to offer 2.5 million shares of its common stock in an initial public offering, or IPO. The biopharma, which uses its proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics, said it expects to price the offering between $11 and $13. The company has applied for listing its shares on the Nasdaq under the ticker symbol IMNM.

Pulmonx Corporation, a commercial-stage MedTech company that provides a minimally invasive treatment for patients with severe emphysema, a form of chronic obstructive pulmonary disease, has filed for a 6.67-million IPO at an estimated price range of $14-$16. The Redwood City, California-based company has applied for listing its shares on the Nasdaq under the ticker symbol LUNG.

IPO Quiet Period Expiry

• PainReform Ltd. (PRFX).