The Week Ahead In Biotech (Aug. 8-14): Jazz Pharma FDA Decision, Earnings Deluge and IPOs In The Spotlight

Biopharma stocks ended higher for the week ending Aug. 6, as the sector latched on to the optimism that was evident in the broader markets. Earnings continued to flow in, triggering stock-specific moves, while clinical readouts also moved stocks during the week.

BeyondSpring Inc. BYSI was among the biggest biopharma gainers of the week, with the stock reacting to a positive late-stage readout for its lung cancer treatment combo. The stock ended the week with a gain of about 128%.

Dicerna Pharmaceuticals, Inc. DRNA, however, was not as fortunate, as the stock lost about one-fifth of its market cap following mixed results from a pivotal trial of its RNAi therapeutic candidate nedosiran in primary hyperoxaluria 1.

The market reacted negatively to earnings from vaccine companies Moderna, Inc. MRNA and Novavax, Inc. NVAX. Moderna's results, although outstanding, elicited negative reaction, while a lack of update about U.S. approval of Novavax' vaccine sent its shares tumbling on Friday.

On the approvals front, the Food and Drug Administration cleared Sanofi SNY's Nexviazyme (avalglucosidase alfa-ngpt), an enzyme replacement therapy drug for Pompe disease.

The IPO news flow tapered off, with ABVC BioPharma, Inc. ABVC, Indaptus Therapeutics, Inc. INDP and Adagio Therapeutics, Inc. Common Stock ADGI among the companies pricing their offerings and listing during the week.

Here are the key catalytic events for the unfolding week:

Conferences:

BTIG Virtual Biotechnology Conference: Aug. 9-10

2021 Wedbush Pacgrow Healthcare Virtual Conference: Aug. 10-11

PDUFA Dates

The FDA is scheduled to rule on Jazz Pharmaceuticals plc's JAZZ's supplemental new drug application for Xywav (JZP-258) as a treatment option for idiopathic hypersomnia in adults. The PDUFA goal by date is Thursday, Aug. 12.

Clinical Readouts

Pending Mid-2021 Releases

F-star Therapeutics, Inc. FSTX: update on the progress of SB 11285 in the phase 1 clinical trial

Crinetics Pharmaceuticals, Inc. CRNX: preliminary Phase 1 data for CRN04894 in Cushing's disease and congenital adrenal hyperplasia and CRN04777 in congenital hyperinsulinism

Praxis Precision Medicines, Inc. PRAX: Preliminary topline data from the Phase 2a trial of PRAX-944 in essential tremor and safety, tolerability and PK data from the ongoing Phase 1 trial of PRAX-562

Kaleido Biosciences, Inc. KLDO: Topline Phase 2 data from a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis

Earnings

Monday

• Dicerna Pharmaceuticals, Inc. DRNA (before the market open)
• Intra-Cellular Therapies, Inc. ITCI (before the market open)
• Eagle Pharmaceuticals, Inc. EGRX (before the market open)
• Epizyme, Inc. EPZM (before the market open)
• Syneos Health, Inc. SYNH (before the market open)
• ShockWave Medical, Inc. SWAV (before the market open)
• Viatris Inc. VTRS (before the market open)
• Rubius Therapeutics, Inc. RUBY (before the market open)
• Biohaven Pharmaceutical Holding Company Ltd. BHVN (before the market open)
• bluebird bio, Inc. BLUE (before the market open)
• BioNTech SE BNTX (before the market open)
• Avadel Pharmaceuticals plc AVDL (before the market open)
• Agenus Inc. AGEN (before the market open)
• Amneal Pharmaceuticals, Inc. AMRX (before the market open)
• Axsome Therapeutics, Inc. AXSM (before the market open)
• Elanco Animal Health Incorporated ELAN (before the market open)
• Amphastar Pharmaceuticals, Inc. AMPH (after the close)
• Atara Biotherapeutics, Inc. ATRA (after the close)
• Aethlon Medical, Inc. AEMD (after the close)
• Adamas Pharmaceuticals, Inc. ADMS (after the close)
• Athersys, Inc. ATHX (after the close)
• Apellis Pharmaceuticals, Inc. APLS (after the close)
• Adaptimmune Therapeutics plc ADAP (after the close)
• Alpine Immune Sciences, Inc. ALPN (after the close)
• Aziyo Biologics, Inc. AZYO (after the close)
• Castle Biosciences, Inc. CSTL (after the close)
• Gossamer Bio, Inc. GOSS (after the close)
• Pulse Biosciences, Inc. PLSE (after the close)
• Recro Pharma, Inc. REPH (after the close)
• NexImmune, Inc. NEXI (after the close)
• ZIOPHARM Oncology, Inc. ZIOP (after the close)
• REGENXBIO Inc. RGNX (after the close)
• Reata Pharmaceuticals, Inc. RETA (after the close)
• ZIOPHARM Oncology, Inc. ZIOP (after the close)
• Ocular Therapeutix, Inc. OCUL (after the close)
• Fulgent Genetics, Inc. FLGT (after the close)
• FibroGen, Inc. FGEN (after the close)
• Organogenesis Holdings Inc. ORGO (after the close)
• Halozyme Therapeutics, Inc. HALO (after the close)
• Syndax Pharmaceuticals, Inc. SNDX (after the close)
• Tricida, Inc. TCDA (after the close)
• Rocket Pharmaceuticals, Inc. RCKT (after the close)
• Inovio Pharmaceuticals, Inc. INO (after the close)
• Penumbra, Inc. PEN (after the close)
• Turning Point Therapeutics, Inc. TPTX (after the close)
• Precigen, Inc. PGEN (after the close)
• Lyra Therapeutics, Inc. LYRA (after the close)
• Celcuity Inc. CELC (after the close)
• Cara Therapeutics, Inc. CARA (after the close)
• Catalyst Pharmaceuticals, Inc. CPRX (after the close)
• ChemoCentryx, Inc. CCXI (after the close)
• Exagen Inc. XGN (after the close)

Tuesday

• Harmony Biosciences Holdings, Inc. HRMY (before the market open)
• TransDigm Group Incorporated TDG (before the market open)
• Marinus Pharmaceuticals, Inc. MRNS (before the market open)
• Fulcrum Therapeutics, Inc. FULC (before the market open)
• BioXcel Therapeutics, Inc. BTAI (before the market open)
• Matinas BioPharma Holdings, Inc. MTNB (before the market open)
• Aptinyx Inc. APTX (before the market open)
• aTyr Pharma, Inc. LIFE (after the close)
• Akoya Biosciences, Inc. AKYA (after the close)
• Talis Biomedical Corporation TLIS (after the close)
• Clearside Biomedical, Inc. CLSD (after the close)
• Bioventus Inc. BVS (after the close)
• ClearPoint Neuro, Inc. CLPT (after the close)
• Inari Medical, Inc. NARI (after the close)
• Cumberland Pharmaceuticals Inc. CPIX (after the close)
• OncoCyte Corporation OCX (after the close)
• Maravai LifeSciences Holdings, Inc. MRVI (after the close)
• KemPharm, Inc. KMPH (after the close)
• Regulus Therapeutics Inc. RGLS (after the close)
• Relmada Therapeutics, Inc. RLMD (after the close)
• Neovasc Inc. NVCN (after the close)

Related Link: Moderna Vs. BioNTech: How Do These High-Flying COVID-19 Vaccine Stocks Compare?

Wednesday

• Haemonetics Corporation HAE (before the market open)
• OptiNose, Inc. OPTN (before the market open)
• Royalty Pharma plc RPRX (before the market open)
• IMV Inc. IMV (before the market open)
• Altimmune, Inc. ALT (before the market open)
• Gamida Cell Ltd. GMDA (before the market open)
• ADMA Biologics, Inc. ADMA (before the market open)
• TELA Bio, Inc. TELA (after the close)
• Navidea Biopharmaceuticals, Inc. NAVB (after the close)
• Evofem Biosciences, Inc. EVFM (after the close)
• Repro Med Systems, Inc. KRMD (after the close)
• Xenon Pharmaceuticals Inc. XENE (after the close)
• VolitionRx Limited VNRX (after the close)
• Cyclacel Pharmaceuticals, Inc. CYCC (after the close)
• MannKind Corporation MNKD (after the close)
• DiaMedica Therapeutics Inc. DMAC (after the close)
• Eyenovia, Inc. EYEN (after the close)
• GeoVax Labs, Inc. GOVX (after the close)
• Histogen Inc. HSTO (after the close)
• Revolution Medicines, Inc. RVMD (after the close)
• Panbela Therapeutics, Inc. PBLA (after the close)

Thursday

• F-star Therapeutics (before the market open)
• Entasis Therapeutics Holdings Inc. ETTX (before the market open)
• Virios Therapeutics, Inc. VIRI (before the market open)
• Synlogic, Inc. SYBX (before the market open)
• Ikena Oncology, Inc. IKNA (before the market open)
• VYNE Therapeutics Inc. VYNE (before the market open)
• Veru Inc. VERU (before the market open)
• Celsion Corporation CLSN (before the market open)
• Organon & Co. OGN (before the market open)
• PDS Biotechnology Corporation PDSB (before the market open)
• Selecta Biosciences, Inc. SELB (before the market open)
• Precision BioSciences, Inc. DTIL (before the market open)
• Apyx Medical Corporation APYX (before the market open)
• Evaxion Biotech A/S EVAX (before the market open)
• HOOKIPA Pharma Inc. HOOK (before the market open)
• CymaBay Therapeutics, Inc. CBAY (after the close)
• Trevi Therapeutics, Inc. TRVI (after the close)
• TFF Pharmaceuticals, Inc. TFFP (after the close)
• Onconova Therapeutics, Inc. ONTX (after the close)
• Achieve Life Sciences, Inc. ACHV (after the close)
• AbCellera Biologics Inc. ABCL (after the close)
• Acutus Medical, Inc. AFIB (after the close)
• Applied DNA Sciences, Inc. APDN (after the close)
• Atea Pharmaceuticals, Inc. AVIR (after the close)
• Brickell Biotech, Inc. BBI (after the close)
• Daré Bioscience, Inc. DARE (after the close)
• BIOLASE, Inc. BIOL (after the close)
• Co-Diagnostics, Inc. CODX (after the close)
• ImmuCell Corporation ICCC (after the close)
• CorMedix Inc. CRMD (after the close)
• Capricor Therapeutics, Inc. CAPR (after the close)
• Lineage Cell Therapeutics, Inc. LCTX (after the close)
• OpGen, Inc. OPGN (after the close)
• PAVmed Inc. PAVM (after the close)
• NeuroPace, Inc. NPCE (after the close)
• Spectrum Pharmaceuticals, Inc. SPPI (after the close)
• Relay Therapeutics, Inc. RLAY (after the close)
• Progenity, Inc. PROG
• Viveve Medical, Inc. VIVE (after the close)
• PolarityTE, Inc. PTE (after the close)
• Dyadic International, Inc. DYAI (after the close)
• Eledon Pharmaceuticals, Inc. ELDN (after the close)
• Helius Medical Technologies, Inc. HSDT (after the close)
• Lucira Health, Inc. LHDX (after the close)
• ThermoGenesis Holdings, Inc. THMO (after the close)

Friday

• Medicenna Therapeutics Corp. MDNA (before the market open)
• GT Biopharma, Inc. GTBP (before the market open)
• Forma Therapeutics Holdings, Inc. FMTX (before the market open)
• Bio-Path Holdings, Inc. BPTH (before the market open)

IPOs

IPO Pricing

Stamford, Connecticut-based Healthcare Royalty, Inc. has filed a preliminary prospectus with the SEC to offer 46.875 million shares in an initial public offering. Royalty is a mid-market royalty acquisition company and focuses on growth assets and emerging companies driving innovation in the biopharmaceutical industry. The company proposes to price the IPO between $15 and $17 per share. It has applied to list its shares on the Nasdaq under the ticker symbol "HCRX."

WCG Clinical, Inc., a Princeton, New Jersey-based provider of clinical trial solutions, focused on providing solutions that are designed to improve the quality and efficiency of clinical research, stimulate growth and foster compliance, has filed to offer 45 million shares in an IPO. The shares, which are estimated to be priced between $15 and $17, are expected to list on the Nasdaq under the ticker symbol "WCGC."

IPO Quiet Period Expiry

• Sera Prognostics, Inc. SERA
• Rapid Micro Biosystems, Inc. RPID
• Sight Sciences, Inc. SGHT
• Imago BioSciences, Inc. IMGO
• TScan Therapeutics, Inc. TCRX
• Erasca, Inc. ERAS
• Regencell Bioscience Holdings Limited RGC
• HCW Biologics Inc. HCWB

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