12:00 AM
Jun 30, 2014
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Basilea Pharmaceutica AG (SIX:BSLN) fell CHF9.10 to CHF104.90 last week after it said FDA confirmed additional Phase III data would be required to support U.S. approval of ceftobiprole to treat pneumonia. The company said it does not plan to conduct new Phase III trials without a U.S. partner.

Gilead Sciences Inc. (NASDAQ:GILD) added $0.76 to $82.94 on Friday after submitting an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Sovaldi sofosbuvir to treat chronic HCV genotype 2 infection. The company already markets Sovaldi in the U.S., EU and Canada to treat HCV infection.

Gilead gained $1.74 on the week.

Hyperion Therapeutics Inc. (NASDAQ:HPTX) was up $0.64 to $26 last week after EMA accepted for review an MAA for Ravicti glycerol phenylbutyrate to treat urea cycle disorders (UCDs).

Hyperion, which markets Ravicti in the U.S. to manage chronic UCDs, has worldwide rights to the compound from Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX).

Look for shares of MannKind Corp. (NASDAQ:MNKD) to move this week. News came in the final hour of trading on Friday that FDA approved a resubmitted NDA for Afrezza to improve glycemic control in Type I and II diabetics.

MannKind shares jumped $2.97 (74%) to $6.99 on April 2 after FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted that Afrezza was safe and effective.

The company was off $0.35 on the week.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) was off $2.51 to $277.29 on Friday. EMA's CHMP backed approval of Eylea aflibercept to treat visual impairment due to diabetic macular edema (DME). Eylea is approved in the U.S. and EU to treat wet age-related macular edema (AMD) and macular edema following central retinal vein occlusion (CRVO). The drug is under FDA review to treat DME, with an Aug. 18 PDUFA date.

Bayer AG (Xetra:BAYN) has ex-U.S. rights to the product from Regeneron, which was off $7.96 on the week.

Clinical milestones

Aerie Pharmaceuticals Inc. (NASDAQ:AERI) jumped $5.95 (28%) to $26.98 on Wednesday after once-daily Roclatan eye drops met the primary endpoint vs. each of its components in a Phase IIb trial to treat glaucoma or ocular hypertension. Roclatan is a fixed-dose combination of the company's Rhopressa eye drops and latanoprost.

Aerie plans to start Phase III testing with Roclatan in mid-2015 and with Rhopressa in July. Rhopressa is a dual inhibitor of Rho kinase and the norepinephrine transporter.

The stock continued to gain to finish the week up $6.86 (35%) to $26.58.

Forest Laboratories Inc. (NYSE:FRX) was up...

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