After a 12 percent jump in value in July, the BioWorld Biopharmaceutical Index is tracking about 1.5 percent lower in August, probably a function of investors taking a summer break concentrating more on the Rio Olympics than the developments in the biopharma space. The Biopharmaceutical Index is currently lagging the general markets, with the Nasdaq Composite index up 1.5 percent and the Dow Jones Industrial average up about 1 percent in the same period. (See BioWorld Biopharmaceutical Index, below.)

Weighing on the group's performance are Biomarin Pharmaceutical Inc. and Incyte Corp. Despite cruising to record quarterly and first-half revenues of $300.1 million and $536.9 million, respectively, thanks to strong performances from Vimizim (elosulfase alfa), approved to treat mucopolysaccharidosis type IVA, and phenylketonuria drug Kuvan (sapropterin dihydrochloride), Biomarin's shares (NASDAQ:BMRN) are down a whopping 23 percent. The dive followed the San Rafael-based company reporting the pricing of an underwritten public offering of 7.5 million shares of its common stock at $96 per share. The company generated $720 million, which it will apply to clinical trials of its product candidates and the expansion of its manufacturing capacity, particularly with respect to its manufacturing capability for its gene therapy program.

Incyte's shares (NASDAQ:INCY) have slipped almost 16 percent so far this month despite also reporting a strong quarter of Jakafi (ruxolitinib) sales. Investors seemed to focus on the company's conservative stance on its oral indoleamine 2,3-dioxygenase 1 inhibitor, epacadostat, now in phase III trials. In a research note, Jefferies analyst Brian Abrahams said he was not "overly concerned" by this approach to conveying signals/updates on epacadostat. "Instead we view it as prudent, given risk in prematurely interpreting data/biomarkers for [immuno-oncology] combos."

SPIN OUT

Leading gainer so far this month is Biogen Inc. whose shares are on a roll (NASDAQ:BIIB), up 8 percent as speculation continues to swirl around its possible acquisition. (See BioWorld Today, Aug. 3, 2016.)

The company gave an identity to its intended spinout of its hemophilia franchise. Bioverativ will be the name of the stand-alone, publicly traded global biotechnology company that it expects to launch in early 2017. It will comprise commercial assets Alprolix (coagulation factor IX [recombinant], Fc fusion protein) and Eloctate (antihemophilic factor [recombinant], Fc fusion protein) and longer-acting factors, along with preclinical lentivirus-based hemophilia gene therapy assets partnered with Fondazione Telethon and Ospedale San Raffaele.

Following completion of the transaction, Bioverativ plans to trade under the symbol BIVV on Nasdaq.

While biopharma's blue chip companies are taking a breather this month from their upswing in valuation, the BioWorld Drug Developers index group members kept pace with the general markets posting an approximately 2 percent increase. (See BioWorld Drug Developers Index, below.)

Leading the gainers is Clovis Oncology Inc., whose shares (NASDAQ:CLVS) are riding a 20 percent jump in value so far in August. Investors are bullish on the prospects following the Boulder, Colo., company updating its clinical development programs and regulatory outlook for the remainder of year during its second-quarter financial results discussions.

The company said it anticipates FDA acceptance for review and a PDUFA date of its PARP 1-3 inhibitor, rucaparib, for the monotherapy treatment of patients with advanced ovarian cancer with deleterious BRCA-mutated tumors (inclusive of both germline and somatic BRCA mutations) previously treated with multiple prior therapies.

The company also reported that its companion diagnostic partner, Foundation Medicine Inc., has submitted a premarket approval application with the FDA for its diagnostic assay designed to identify both germline and somatic BRCA mutations. The timing of the submission is expected to allow for regulatory approval of the companion diagnostic at substantially the same time that rucaparib could be approved.

On the other side of the coin, Sangamo Biosciences Inc.'s shares (NASDAQ:SGMO) have slipped 30 percent month-to-date, mainly due to delays in multiple zinc finger nuclease (ZFN) gene-editing programs and concerns expressed by analysts on management execution capability.

The company has eight programs in therapeutic development in addition to ongoing clinical trials to evaluate its ZFN-mediated genome-editing approach for HIV/AIDS in T cells as well as hematopoietic stem and progenitor cells.