Biotech week ahead, Nov. 2

Biotech stocks continued to sway to the tunes of the broader market in the week ended Oct. 30, which succumbed to geopolitical and macroeconomic concerns.

Several big-name pharma companies, including Merck & Co. Inc. MRK 0.3% and Pfizer Inc. PFE 0.08%, reported earnings during the week. The earnings news flow was broadly mixed.

Catabasis Pharmaceuticals Inc CATB 1.47% was among the biggest decliners, as it halted a late-stage trial of its Duchenne muscular dystrophy drug.

On the other hand, Scholar Rock Holding Corp. SRRK 8.11% was up about over 175% during the week, reacting to positive mid-stage results for spinal muscular atrophy drug.

On the COVID-19 front, Regeneron Pharmaceuticals Inc. said it is REGN 1.57% halting the Phase 3 trial of its antibody cocktail in patients with severe COVID-19, citing safety issue.

Kala Pharmaceuticals Inc. KALA 2.67% announced FDA approval for its dry eye disease drug, while Spectrum Pharmaceuticals Inc. SPPI 2.58% communicated a delay in the decision for its treatment option for chemotherapy-induced neutropenia, as the FDA could not inspect a plant in South Korea due to COVID-19.

Here're the key catalysts for the unfolding week:

 

Conferences

 

• International Cytokine and Interferon Society's Cytokines, or, ICIS, 2020 Conference – Nov. 1–5
• 13th Clinical Trials on Alzheimer's Disease, or CTAD: Nov. 4-7

 

Adcom Calendar

 

FDA's Peripheral and Central Nervous System Drugs Advisory Committee will discuss Friday Biogen Inc's BIIB 0.8% BLA for its Alzheimer's treatment candidate aducanumab. On Nov. 4, the FDA will release briefing document that has the potential to move the stock.

Outperformance of Biogen hinges on a positive regulatory verdict for aducanumab, according to SVB Leerink analyst Marc Goodman.

Clinical Readouts/Presentations

 

Surface Oncology Inc. SURF 5.58% is scheduled to present at the ICIS congress, preclinical data on SRF388, a first in class IL-27 blocking antibody, in clinical trials for patients with cancer. (Sunday. 5:30 pm-7:30 pm)

vTv Therapeutics Inc. VTVT 2.89% will make an oral presentation at the CTAD, providing a general study update and data on the baseline characteristics of patients enrolled in the ongoing phase 2 Elevage Study of azeliragon as a potential treatment for mild-probable Alzheimer's disease in adult patients who also have type 2 diabetes. (Wednesday, 1am)

Bellerophon Therapeutics Inc. BLPH 2.2% will present at the American Thoracic Society Interstitial Lung Disease Mini Symposia as well as the 2020 Pulmonary Fibrosis Foundation Meeting, data from its Phase 2 study of INOpulse for the treatment of fibrotic interstitial lung disease patients at risk for pulmonary hypertension. (Thursday)

Cassava Sciences Inc. SAVA 2.91% is due to present at the CTAD conference, results of its Phase 2b study of sumifilam in Alzheimer's disease. (Saturday, 11:10 am)

 

Earnings

 

Monday

• IVERIC bio Inc. ISEE 1.5% (before the market open)
• Eagle Pharmaceuticals Inc. EGRX 1.77% (before the market open)
• Intersect ENT Inc XENT 2.76% (before the market open)
• Horizon Therapeutics PLC HZNP 0.3% (before the market open)
• Minerva Neurosciences Inc NERV 0.65% (before the market open)
• Jazz Pharmaceuticals PLC JAZZ 0.95% (after the close)
• Neuronetics Inc STIM 9.39% (before the market open)
• Inspire Medical Systems Inc INSP 32.24% (before the market open)
• Veracyte Inc VCYT 9.2% (before the market open)
• Syndax Pharmaceuticals Inc. SNDX 10.88% (before the market open)
• Halozyme Therapeutics Inc. HALO 11.34% (before the market open)
• Esperion Therapeutics Inc. ESPR 16.52% (before the market open)
• Urovant Sciences Ltd. UROV 6.73% (before the market open)
• DURECT Corporation DRRX 6.78% (before the market open)
• SI-Bone Inc SIBN 4.49% (before the market open)
• Karyopharm Therapeutics (Inc NASDAQ: KPTI)
• Pacific Biosciences of California Inc PACB 4.08%

Tuesday

• Oxford Immunotec Global PLC OXFD 14.25% (before the market open)
• Catalent Inc CTLT 7.91% (before the market open)
• Avanos Medical Inc. AVNS 8.65% (before the market open)
• Acorda Therapeutics Inc. ACOR 1.82% (after the close)
• Five Prime Therapeutics Inc. FPRX 3.88% (after the close)
• GW Pharmaceuticals PLC- ADR GWPH 21.19% (after the close)
• Supernus Pharmaceuticals Inc. SUPN 1.2% (after the close)

Related Link: Aldeyra Has 'Catalayst-Rich' 12 Months Ahead, Jefferies Says In Bullish Initiation

Wednesday

• Haemonetics Corp. HAE 0.58% (before the market open)
• Aquestive Therapeutics Inc. AQST 10.42% (after the close)
• Anika Therapeutics Inc. ANIK 5.8% (after the close)
• Axonics Modulation Technologies Inc. AXNX 6.01% (after the close)
• ACADIA Pharmaceuticals Inc. ACAD 2.1% (after the close)
• T2 Biosystems Inc. TTOO 2.27% (after the close)
• OraSure Technologies, Inc. OSUR 0.64% (after the close)
• Hologic Inc. HOLX 1.93% (after the close)
• Otonomy Inc. OTIC 1.44% (after the close)
• SurModics Inc. SRDX 1.17% (after the close)
• Sangamo Therapeutics Inc. SGMO 2.6% (after the close)
• PRA Health Sciences Inc. PRAH 3.63% (after the close)
• Cytosorbents Corp. CTSO 7.21% (after the close)
• Lineage Cell Therapeutics Inc. LCTX 4.7% (after the close)
• Insulet Corp. PODD 3.3% (after the close)
• Cytokinetics Inc. CYTK 4.83% (after the close)
• MannKind Corp. MNKD 2.5% (after the close)
• Flexion Therapeutics Inc. FLXN 0.17% (after the close)
• DiaMedica Therapeutics Inc. DMAC 4.09% (after the close)
• Orthopediatrics Corp. KIDS 3.79%)
• Ionis Pharmaceuticals Inc. IONS 0.49%
• G1 Therapeutics Inc. GTHX 3.39%
• Spectrum Pharmaceuticals Inc. SPPI 2.58%

Thursday

• Kura Oncology Inc. KURA 6.31% (before the market open)
• Synlogic Inc. SYBX 0.54% (before the market open)
• Regeneron (before the market open)
• Bristol-Myers Squibb Co. BMY 2.94% (before the market open)
• Arbutus Biopharma Corp. ABUS 4.71% (before the market open)
• Alnylam Pharmaceuticals Inc. ALNY 3.31% (before the market open)
• Athenex Inc ATNX 3.55% (before the market open)
• Adaptimmune Therapeutics PLC – ADR ADAP 1.55% (before the market open)
• ANI Pharmaceuticals Inc Common Stock ANIP 2.22% (before the market open)
• Antares Pharma Inc. ATRS 6.07% (before the market open)
• Agios Pharmaceuticals Inc. AGIO 3.26% (before the market open)
• X4 Pharmaceuticals Inc. XFOR 4.68% (before the market open)
• SAGE Therapeutics Inc. SAGE 3.56% (before the market open)
• Intellia Therapeutics Inc. NTLA 3.91% (before the market open)
• Kala Pharmaceuticals Inc. KALA 2.67% (before the market open)
• OptiNose Inc. OPTN 6.55% (before the market open)
• Orthofix Medical Inc. OFIX 3% (before the market open)
• Radius Health Inc RDUS 0.46% (before the market open)
• Repligen Corp. RGEN 4.63% (before the market open)
• Incyte Corp. INCY 0.6% (before the market open)
• Eyepoint Pharmaceuticals Inc. EYPT 2.97% (before the market open)
• Concert Pharmaceuticals Inc. CNCE 2.97% (before the market open)
• Clovis Oncology Inc. CLVS 5.44% (before the market open)
• Vericel Corp. VCEL 9.64% (before the market open)
• Provention Bio Inc. PRVB 4.51% (before the market open)
• Harvard Bioscience Inc. HBIO 7.8% (before the market open)
• BioCryst Pharmaceuticals, Inc. BCRX 2.73% (before the market open)
• BioDelivery Sciences International, Inc. BDSI 3.42% (before the market open)
• Amarin Corporation plc AMRN 1.01% (before the market open)
• Y-mAbs Therapeutics Inc. YMAB 2.7% (after the close)
• AcelRx Pharmaceuticals Inc. ACRX 0.55% (after the close)
• Aerie Pharmaceuticals Inc. AERI 0.82% (after the close)
• Adamas Pharmaceuticals Inc. ADMS 2.65% (after the close)
• Transenterix Inc. TRXC 0.6% (after the close)
• Paratek Pharmaceuticals Inc. PRTK 1.75% (after the close)
• Nektar Therapeutics NKTR 2.17% (after the close)
• Spero Therapeutics Inc. SPRO 8.02% (after the close)
• Misonix Inc. MSON 1.93% (after the close)
• TFF Pharmaceuticals Inc TFFP 3.61% (after the close)
• Xencor Inc XNCR 4.51% (after the close)
• Oyster Point Pharma Inc. OYST 1.78% (after the close)
• Sarepta Therapeutics Inc. SRPT 2.95% (after the close)
• Natera Inc. NTRA 5.89% (after the close)
• ICU Medical Inc. ICUI 3.11% (after the close)
• Rigel Pharmaceuticals, Inc. RIGL 2% (after the close)
• Guardant Health Inc GH 2.47% (after the close)
• Retrophin Inc RTRX 2.93% (after the close)
• Tandem Diabetes Care Inc TNDM 4.69% (after the close)
• Chembio Diagnostics Inc CEMI 1.51% (after the close)
• Dicerna Pharmaceuticals Inc DRNA 2.84% (after the close)
• Exelixis, Inc. EXEL 2.33% (after the close)
• Endo International PLC ENDP 2.86% (after the close)
• FibroGen Inc FGEN 2.09% (after the close)
• Fluidigm Corporation FLDM 6.95% (after the close)
• Nevro Corp NVRO 2.53% (after the close)
• CytomX Therapeutics Inc CTMX 2.67% (after the close)
• Dynavax Technologies Corporation DVAX 6.38% (after the close)
• Geron Corporation GERN 2.29% (after the close)
• CorMedix Inc. CRMD 8.43% (after the close)
• Celcuity Inc CELC (after the close)
• BioLife Solutions Inc BLFS 4.57% (after the close)
• Caladrius Biosciences Inc CLBS 4.64% (after the close)
• Theravance Biopharma Inc TBPH 1.29% (after the close)
• Global Blood Therapeutics Inc GBT 2.9% (after the close)
• Coherus Biosciences Inc CHRS 2.89% (after the close)
• Iovance Biotherapeutics Inc IOVA 1.81%
• AtriCure Inc. ATRC 5.8%
• Acceleron Pharma Inc XLRN 1.6%
• ADMA Biologics Inc ADMA
• Ocular Therapeutix Inc OCUL 0.66%
• Ironwood Pharmaceuticals, Inc. IRWD 1.95%
• Syros Pharmaceuticals Inc SYRS 9.86%
• ZIOPHARM Oncology Inc. ZIOP
• Sensus Healthcare Inc SRTS 1.24%
• Deciphera Pharmaceuticals Inc DCPH 4.73%
• Eloxx Pharmaceuticals Inc ELOX 8.68%
• Chiasma Inc CHMA 0.54%
• Emergent Biosolutions Inc EBS 1.91%
• INmune Bio Inc INMB 7.72%
• Calithera Biosciences Inc CALA 1.15%

Friday

• Mylan NV MYL (before the market open)
• Amphastar Pharmaceuticals Inc AMPH 2.36% (before the market open)
• Amneal Pharmaceuticals Inc AMRX 2.46% (before the market open)
• Elanco Animal Health Inc ELAN 1.82% (before the market open)
• Matinas BioPharma Holdings Inc MTNB 0.24% (before the market open)
• Zimmer Biomet Holdings Inc ZBH 3% (before the market open)

 

IPO Analysts' Quiet Period Expiry

 

• Aziyo Biologics Inc AZYO 4.26%
• Kronos Bio Inc KRON 0.93%
• Spruce Biosciences Inc SPRB 4.33%

https://www.benzinga.com/general/biotech/20/11/18157255/the-week-ahead-in-biotech-nov-1-7-adcom-test-for-biogens-aducanumab-alzheimers-conference-smid-ca

Inovio Responds To Partial Clinical Hold On COVID Vax Candidate, Sees FDA Reply This Month

Inovio Pharmaceuticals Inc INO 2% responded to the FDA's questions about INO-4800 and the Cellectra vaccine delivery device in October, the company confirmed to Benzinga.

Inovio Continues Phase 2/3 Trial Prep: The FDA imposed a partial clinical hold in September on the planned Phase 2/3 clinical study of INO-4800, its DNA vaccine candidate against the novel coronavirus.

When announcing the partial hold in late September, Inovio said the regulatory action had nothing to do with the expanded, ongoing Phase 1 study. 

The FDA is mandated to reply to the response submitted by the company within 30 days.

"We look forward to hearing back from the FDA in November and continue to prepare for a planned phase-II/III trial of INO-4800," Inovio said in a statement. 

What's Next For Inovio: Inovio is scheduled to report its third-quarter results Monday after the close.

The company may shed some light on the potential resolution of the partial clinical hold and the vaccine timeline in the earnings report or in the call.

https://www.benzinga.com/general/biotech/20/11/18185997/inovio-responds-to-partial-clinical-hold-on-covid-19-vaccine-candidate-expects-fda-reply-this-mon

GW Pharmaceuticals Revenue Hits $137M, Tests Another Cannabis Plant-Based Drug

Biopharmaceutical company GW Pharmaceuticals plc GWPH 21.19% revealed Tuesday that its revenue for the third quarter hit $137.1 million, up by 51% year-over-year.

For the first nine months of this fiscal year, total revenue amounted to $378.6 million versus $202.3 million for the same period of 2019.

For the quarter, net loss was $12.2 million, down by 13.1% compared to last year's corresponding quarter.

As of Sept. 30, the company had $480.3 million in cash and cash equivalents.

GW Pharmaceuticals also reported "strong revenue growth" in the third quarter "despite the challenges presented" by the current health crisis, GW chief executive Justin Gover said.

Over the quarter, the CBD epilepsy drug — Epidiolex — generated $132.6 million in net sales. In August, the FDA approved the expansion of the indication for the drug.

Besides treating those suffering from seizures linked to Lennox-Gastaut and Dravet syndromes, the plant-derived CBD medicine can also manage seizures related to tuberous sclerosis complex.

"Epidiolex meets a serious unmet need within the field of epilepsy, and we expect the product to demonstrate continued strong growth in the months and years ahead," Gover continued. The expanded indication for the drug "has been very well received by patients, clinicians, and payers," he added.

GW Seizes Second Product Opportunity In The US

Simultaneously, the Carlsbad, California-based company, and its US subsidiary Greenwich Biosciences confirmed the launch of GW's first US Phase 3 clinical trial evaluating nabiximols for multiple sclerosis-associated spasticity. It's one of five studies for nabiximols in MS spasticity.

The company anticipates a positive result would enable an NDA submission by mid- next year.

Nabiximols — also known as Sativex — is extracted from the cannabis plant, and it comes in the form of an oral spray.

Gover disclosed that US Phase 3 clinical program is recruiting patients. He believes they have a "clear path to an NDA submission, potentially as soon as next year."

https://www.benzinga.com/general/biotech/20/11/18189819/gw-pharmaceuticals-revenue-hits-137m-tests-another-cannabis-plant-based-drug