The Daily Biotech Pulse: FDA Nod For Lilly, Regulus Slumps On Study Discontinuation, ObSeva Strikes Linzagolix Commercialization Deal

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

Revance Clarifies Gabellar Line Treatment Review On Track

Responding to the public disclosure of its Form 483 pursuant to a Freedom of Information Act request that was directed to the Food and Drug Administration, Revance Therapeutics, Inc. RVNC said its biologics license application for DaxibotulinumtoxinA for Injection remains under review. The company said it continues to anticipate FDA approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines in 2021.

Revance's stock plunged 25% in Tuesday's regular session after the FDA inspectors said in the Form 483 that they found issues with one of the company's facilities.

After Revance's clarification, its stock was up 6.65% at $21.81 in premarket trading.

Click here to access Benzinga's FDA Calendar

Homology Medicines Gets Clearance For Commencing Study of Gene Editing Candidate In Phenylketonuria

Homology Medicines, Inc. FIXX said the pheEDIT Phase 1 clinical trial for HMI-103, a one-time, in vivo product candidate that utilizes a gene editing approach for phenylketonuria, received investigational new drug application clearance from the FDA.

HMI-103, the company said, will be the world's first gene editing candidate for PKU to enter clinical trials from Homology's dual gene therapy and gene editing technology platform.

The stock was adding 3.5% to $6.80 in premarket trading.

Regulus to Shelve Study of First-gen Polycystic Kidney Disease Drug to Prioritize Next-gen Compound For Same Indication

Regulus Therapeutics, Inc. RGLS announced the prioritization of its next-generation candidate, RGLS8429, for the treatment of autosomal dominant polycystic kidney disease. Citing likely limitations on dose and duration of therapy, Regulus said it is planning to discontinue the development of RGLS4326. RGLS4326 was being evaluated in a Phase 1b study in ADPKD patients.

The stock was slumping 23.97% to 57.75 cents in premarket trading.

Lilly's Drug Approved to Treat Some Early-stage Breast Cancer Patients

Eli Lilly LLY said the FDA approved its Verzenio, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of 20% or more, as determined by an FDA-approved test.

Crispr Announces Positive Phase 1 Data For CAR-T Cell Therapy In Lymphoma Patients

CRISPR Therapeutics AG CRSP announced updated results from the Phase 1 study of CAR-T cell therapy CTX110, showing 58% overall response rate and 38% complete response rate in large B-cell lymphoma with a single dose of CTX110 at dose Level 2 and above on an intent-to-treat basis.

Durable responses in LBCL were achieved with 6-month CR rate of 21% and longest response ongoing at over 18 months after initial infusion, the company added.

Based on these encouraging results, the company said it is planning to expand CARBON into a potentially registrational trial in the first quarter of 2022.

The stock was retreating 6.72% to $95.70 in premarket trading.

ObsEva Announces Commercialization Deal For Linzagolix, Debt Financing Agreement

ObsEva SA OBSV announced a strategic relationship with Syneos Health, Inc. SYNH to commercialize linzagolix, its investigational asset for uterine fibroids.

ObsEva said it has also entered into a convertible note financing agreement with certain funds and accounts managed by JGB Management, Inc. which is structured to provide up to $135 million in borrowing capacity, available in nine tranches.

Intellia to Out-license Genomic Editing Tech For Developing Ocular Disease Treatments

Intellia Therapeutics, Inc. NTLA and SparingVision, a genomic medicine company developing treatments for ocular diseases, announced a strategic collaboration to develop novel genomic medicines utilizing CRISPR/Cas9 technology for the treatment of ocular diseases.

As part of this collaboration, Intellia will grant SparingVision exclusive rights to its proprietary in vivo CRISPR/Cas9-based genome editing technology for up to three ocular targets addressing diseases with significant unmet medical need.

Intellia will receive a 10% equity ownership stake in SparingVision and will also be eligible to receive certain development and commercial milestone payments, amounting to around $200 million per product, as well as royalties on potential future sales of products arising from the collaboration.

BiomX Announces Licensing of Atopic Dermatitis Product Candidate In Japan

BiomX Inc. PHGE announced today that it has entered into an agreement granting Maruho, a dermatology-focused Japanese pharma company, a right of first offer to license BiomX's atopic dermatitis product candidate, BX005, in Japan.

The stock was up 14.3% at $3.12 in premarket trading.

Preannouncements

CytoSorbents Corporation CTSO preannounced third-quarter revenues of $9.7 million, down 8% year-over-year. Analysts, on average, estimated revenues of $11.96 million. The company expects third-quarter CytoSorb product sales to decline 13% and COVID-19-related product sales to decline from $2.7 million to $1.1 million. On the other hand, core non-COVID-19 product sales were up 4%.

The stock was down 9.52% at $6.27 in premarket trading.

Sarepta Therapeutics, Inc. SRPT said it expects its net product revenues for the third quarter to be approximately $166.9 million, compared to net product revenues of $121.4 million for the same period of 2020. The consensus estimates call for revenues of $167.73 million.

Separately, the company said it is offering to sell, subject to market and other conditions, $500 million worth of its common stock in an underwritten public offering.

Sarepta shares were moving down 6.61% to $88.79 in premarket trading.

Neuronetics, Inc. STIM said it expects total third-quarter revenue of about $13.8 million, compared to previously issued guidance of $15 million to $16 million.

"Our third quarter revenue came in lower than anticipated primarily due to our new sales team requiring additional time to get to full productivity as a result of extended sales cycles driven in part by the uncertain Covid-19 environment," the company said.

Accordingly, the company now expects full-year revenue to be in the range of $53.3 million to $54.3 million.

Analysts, on average, estimate revenues of $15.07 million for the third quarter and $59.33 million for the full year.

The stock was slipping 22.50% to $4.96 in premarket trading.

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

On The Radar

PDUFA Dates

Clinical Readouts

Atara Biotherapeutics, Inc. ATRA will present at the 37th Congress of the European Committee for Treatment and Research In Multiple Sclerosis, updated open-label extension clinical data and new magnetization transfer ratio imaging data from a Phase 1 study of ATA188. ATA188 is an off-the-shelf, allogeneic Epstein-Barr virus-targeted T-cell immunotherapy for progressive multiple sclerosis.

Earnings

Theratechnologies Inc. THTX (before the market open)