PDUFA

Food and Drug Administration decisions and advisory committee verdicts slated for November were mostly positive. New molecular entity approvals so far this year trail 2021’s tally by about 35%. The two NMEs that were okayed in November include Provention Bio, Inc.’s...

April turned out to be a productive month in terms of drug approvals, with the FDA issuing positive verdicts on almost all applications for which decisions were due. The month saw the approval of five new molecular entities, which are drugs with active ingredients that have not been approved...

Biotech stocks came under selling pressure in February, although the degree of weakness was not as worse as the broader market, thanks to strong upward moves by stocks that are levered to COVID-19 epidemic. The FDA approved three new molecular entities, or NMEs, in February, taking the total number...

Biotech stocks have come under some selling pressure in the new year. However, January did witness some strong stock-specific upward moves, especially with stocks leveraged to the Wuhan coronavirus epidemic. PDUFA dates are binary events that invariably serve as make-or-break catalysts for stocks....

Biotech stocks had a fairly robust November, with the iShares NASDAQ Biotechnology Index (NASDAQ: IBB) advancing over 10% for the month. This compares to the 3% gains for the S&P 500 Index. The month witnessed eight new molecular entity, or NME, approvals, taking the total NME approvals for the...

The FDA worked overtime in October, deciding on the fate of several therapies and treatment options. Most reviews produced positive outcomes. Three new molecular entities, or NMEs, were approved in October, taking the total number of NME approvals for the year to 33 compared to 47 approvals by the...

FDA activity remained brisk in August. The FDA gave its nod for a majority of drugs that came up for review, although Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)'s jet lag disorder drug Hetlioz and Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Duchenne muscular dystrophy drug golodirsen failed to...

Though light in terms of PDUFA events, July yielded mostly positive results. Quiet a few approvals came through, including Eli Lilly And Co (NYSE: LLY)'s nasally administered low blood sugar drug, Karyopharm Therapeutics Inc (NASDAQ: KPTI)'s Selinexor and a handful of generic drugs. With...

The FDA went overdrive in the month of June, deciding on several regulatory applications before the July 4 holiday. There were favorable outcomes as well as disappointments. Acer Therapeutics Inc (NASDAQ: ACER) went about a freefall, shedding about 79% in a single session after the FDA issued a...

The FDA approval machinery worked overtime in May, with several new labelings, original approvals and new molecule approvals coming through in the month. The month saw the approval of two new molecular entities, or NMEs: Novartis AG (NYSE: NVS)'s Piqray in combination with fulvestrant to treat...

Biotech stocks bucked the broader market uptrend in April, thanks to the volatility associated with the sector. Some of the catalysts that drove stocks include clinical trial readouts, capital raising and regulatory decisions. PDUFA dates are deadlines for the FDA to review new drugs. The FDA is...

Biotech stocks had a fairly decent outing in February, with the iShares NASDAQ Biotechnology Index (NASDAQ: IBB) adding roughly 2.7 percent for the month compared to the 3 percent gain for the S&P 500 Index. After the government shutdown-related slackness in January, FDA review picked up in...

The year got off to a slow start for the pharma sector from the perspective of regulatory decisions, with the partial government shutdown not helping matters. FDA Commissioner Scott Gottlieb clarified that applications submitted before the shutdown will be reviewed using its limited carryover...

The year is drawing to the close, and biotech stocks have had a fairly good run despite the market-wide downturn in October and Novmeber. New molecular moiety (NME) approvals thus far this year totaled 52, already beating the previous year's number of 46. NMEs are active moieties that...

October was a volatile month for the markets, and biotech stocks were no exception. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) had slipped about 17 percent in the period. This compares to S&P 500's 7 percent retreat. As we enter the last leg of the year, here are a few PDUFA...