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Expert Financial Analysis and Reporting

Post archive for ‘Company Reports’

Northwest Biotherapeutics: 8-K Document Released Today Provides New and Very Interesting Data on Patients Treated with DCVax-L. (NWBO, Buy, $0.48)

Substance of 8-K Regulatory Document Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been raised due to some postings on message boards. Negative blogs have contended that NWBO has included the clinical data from 32 pseudo-progressors in the clinical data base of 331 patients enrolled in the phase […]

Northwest Biotherapeutics: Partial Clinical Hold on Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma is Lifted (NWBO, Buy, $0.45)

Key Points: Lifting of the partial hold removes a cloud that has been overhanging the Company for the past 18 months. We may see topline data on the phase 3 trial by mid-summer or possibly in a late breaker paper at ASCO in May. Linda Liau, principal investigator on the phase 3 trial, is encouraged […]

AMAG Pharmaceuticals: Will FDA Approve Makena SC (AMAG, Neutral, $21.75)

Importance of Makena SC to AMAG? AMAG is engaged in a high stakes clinical development program in which it is endeavoring to gain approval of a subcutaneous dosage form of its key drug Makena. Management has guided that sales of Makena reached $333 to $336 million in 2016 (about 63% of total sales) and issued […]

Cytokinetics: Discussion of Financing Deal with Royalty Partners (CYTK, Buy, $11)

Terms and Implications of This Deal Cytokinetics announced that it had concluded a deal to sell a portion of the future royalty stream on omecamtiv to Royalty Partners, perhaps the leading purveyor of this type of financial instrument. Omecamtiv is partnered with Amgen and recently entered the phase 3 GALACTIC HF trial which will enroll […]

AMAG and Antares: Update on the Development of Makena SC (AMAG, Neutral, $24.40) (ATRS, Buy, $2.04)

Key Points: Recent announcement that AMAG will not pursue Orphan Drug Exclusivity for Makena SC has hammered the stock of AMAG, but has had only a modest effect on ATRS. I believe that this does not change the commercial opportunity for Makena SC over the next two to three years. This potentially could move the […]

Bristol-Myers Squibb: Disappointing Recent Press Release Causes Sharp Drop in Stock Price; I Remain at Buy (BMY, Buy, $49)

The New Press Release Bristol-Myers Squibb’s stock declined from $55.49 at the close on Thursday January 19 to $49.23 at the close on Friday January 20. This was due to a terse press release on January 20th that read “Bristol-Myers Squibb Company announced today that it has decided not to pursue an accelerated regulatory pathway […]

Bristol-Myers Squibb: Implications of Potentially Earlier than Expected Introduction of Keytruda Combined with Chemotherapy in the First Line Lung Cancer Setting (BMY, Buy, $56.31)

Investment overview Yesterday, BMY traded down sharply due to President-elect Trump’s statements on drug pricing and Merck’s announcement that the FDA has accepted a sBLA filing for the combination of Keytruda and chemotherapy (pemetrexed plus carboplatin) for the treatment of first-line metastatic or advanced non-squamous NSCLC. This report only deals with the Merck announcement. In […]

SmithOnStocks Top Stock Picks for 2017, January 3, 2017

Purpose of this Report I last summarized my stock recommendations in a September 12, 2016 report. There has been little change in my thinking or my recommendations since then on most stocks in my universe, but I did issue a Buy on Bristol-Myers Squibb and a sell on Juno Therapeutics. You may want to revisit […]

Northwest Biotherapeutics: DCVax-L Viewed Through the Eyes of Dr. Linda Liau, Lead Investigator on the Phase 3 Trial of DCVax-L (NWBO, $0.35, Buy)

Principal Takeaway Messages  from This Report Dr. Linda Liau believes that use of DCVax-L can result in 25% of glioblastoma patients living four years or longer. This therapeutic effect is comparable to that seen with the checkpoint inhibitors Opdivo and Keytruda in certain refractory solid tumors and in her opinion should result in approval. She […]

Updating My Investment Thinking on Kite (KITE, Avoid, $47.63) and Juno (JUNO, Sell, 17.86) in the Aftermath of the ASH Meeting

Introduction to Report I was closely watching the Amercian Society of Hematology (ASH) meeting held during December 3 to 6 for any meaningful new data on the CAR-T products: Kite’s KTE-C19, Juno’s JCAR-015 and JCAR-017 and Novartis’ CTL-019. There wasn’t anything really earthshaking that came out of ASH, but there were a few tidbits of […]