The Daily Biotech Pulse: ViiV's Long-Acting HIV Drug Meets Study Goal, Chinese Cheer For FibroGen, Retrophin Flunks Late-Stage Study

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on Aug. 21)

• Apellis Pharmaceuticals Inc APLS
• Arrowhead Pharmaceuticals Inc ARWR
• AstraZeneca plc AZN(advanced despite reporting negative results for its lung cancer drug)
• Bioanalytical Systems, Inc. BASI
• Cardiovascular Systems Inc CSII
• DexCom, Inc. DXCM
• Lipocine Inc LPCN
• NextCure Inc NXTC
• Nevro Corp NVRO
• Novocure Ltd NVCR
• Recro Pharma Inc REPH

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 21)

• Abeona Therapeutics Inc ABEO
• Artelo Biosciences Inc ARTL
• Avanos Medical Inc AVNS
• CAN-FITE BIOPHA/S ADR CANF
• KemPharm Inc KMPH
• Meridian Bioscience, Inc. VIVO
• Nektar Therapeutics NKT
• Obalon Therapeutics Inc OBLN
• STRATA Skin Sciences Inc SSKN

Stocks In Focus

ViiV's Long-Acting HIV Drug Combo Aces Late-Stage Trial

ViiV Healthcare, majority owned by GlaxoSmithKline plc GSK, with Pfizer Inc. PFE and SHIONOGI & CO L/ADR SGIOY also as its shareholders, announced positive results from a Phase 3 study dubbed ATLAS-2M study that evaluated an investigational, long-acting, injectable 2-drug regimen of its cabotegravir and Johnson & Johnson JNJ unit Janssen's rilpivirine for treating HIV.

ViiV noted that the study met its primary endpoint, showing that the long-acting regimen of the drug combo, injected every two months was non-inferior to cabotegravir and rilpivirine administered every month at Week 48.

"The ATLAS-2M study results mean that people living with HIV could maintain viral suppression with six total treatments per year, instead of a daily oral treatment 365 times per year. Approval of this regimen would mark a significant change in the HIV treatment paradigm," ViiV said.

Beigene's Lymphoma Accepted For Regulatory Review

Beigene Ltd BGNE said the FDA has accepted its NDA for zanubrutinib for the treatment of patients with mantle cell lymphoma, who have received at least one prior therapy. The PDUFA date for the application, which has a priority review designation, is set for Feb. 2020.

The stock rose 1.34% to $148 in after-hours trading.

FibroGen's Gets Label Expansion For Roxadustat In China

FibroGen Inc FGEN said the National Medical Products Administration, or NAMPA, in China has approved an expansion of the marketing authorization of roxadustat to include treatment of anemia in chronic kidney disease, or CKD, patients who are not dialysis-dependent.

Earlier in Dec. 2018, the NMPA had approved the drug for the treatment of anemia associated with CKD in patients who are dialysis-dependent. FibroGen is collaborating with partner AstraZeneca in developing roxadustat in China.

Retrophin Neurodegeneration Drug Fails In Late-Stage Study

Retrophin Inc RTRX said the Phase 3 FORT study that evaluated the safety and efficacy of fosmetpantotenate compared to placebo in patients with pantothenate kinase-associated neurodegeneration did not meet its primary endpoint and did not demonstrate a difference between treatment groups. The study also did not meet its secondary endpoint, the company said.

Fosmetpantotenate, however, was observed to be generally safe and well-tolerated in the study.

Merck, Themis To Collaborate On Vaccine Research

Merck & Co., Inc. MRK and Themis, a privately-held biotech, announced an exclusive license agreement for the discovery and development of undisclosed vaccine candidates using the latter's measles virus vector-based platform.

The agreement provides for Themis developing vaccine candidates against an undisclosed disease target. Merck is to provide research funding and make an equity investment in Themis. Themis also stands eligible to receive development and sales milestone payments up to the potential value of approximately $200 million as well as royalties on approved products from the collaboration.

KaryoPharm's XPovio Phase 2 Data Published In NEJM

Karyopharm Therapeutics Inc KPTI announced publication of the results of the Phase 2b STORM study evaluating its recently approved multiple myeloma drug Xpovio in the New England Journal of Medicine.

Data from the study showed that oral Xpovio combined with dexamethasone, twice weekly, resulted in a response rate of 26% in heavily pretreated patients.

"We are pleased to have the STORM study results published in such a highly esteemed, peer-reviewed journal and this publication further supports the potential utility of oral XPOVIO in patients with highly refractory multiple myeloma," said Sharon Shacham, Chief Scientific Officer of Karyopharm.

The stock slipped 1.83% to $9.14 in after-hours trading.