Drugs like IMGN 853 are the benefactors of this policy. Although IMGN 853 may also qualify for Breakthrough Therapy Designation.
Qualifying Criteria for Breakthrough Therapy Designation
Breakthrough therapy designation applies to the drug (either alone or in combination with other
drugs) and the specific use for which it is being studied. The term drug refers to the combination
of two or more drugs if the combination is the subject of the breakthrough therapy designation or
request. Where appropriate, FDA may grant designation to the development of a new use of an
1. Serious Condition
2. Existing (or Available) Therapies
3. Preliminary Clinical Evidence
4. May Demonstrate Substantial Improvement on Clinically Significant Endpoint(s)
Features of Breakthrough Therapy Designation
1. Intensive Guidance on an Efficient Drug Development Program, Beginning as
Early as Phase 1
2. Organizational Commitment Involving Senior Managers
3. Submission of Portions of an Application (Rolling Review)
So for you option traders, does this mean today starts the short squeeze and we may have up to 8 trading days to enjoy new highs?
IMGN has skyrocketed 14.7% to sit at $16.54, and earlier notched an annual high of $16.63, despite the lack of a clear driver. The stock's 30-day at-the-money implied volatility has soared 16.1% to 68.6% -- in the 79th percentile of its annual range -- and calls are running at twice the average afternoon clip, with bullish buy-to-open action spotted at the July 16 call.
As with OHRP, today's affinity for long calls marks a change of pace for IMGN. On the International Securities Exchange (ISE), Chicago Board Options Exchange (CBOE), and NASDAQ OMX PHLX (PHLX), the stock's 50-day put/call volume ratio of 0.36 stands higher than 77% of all other readings from the past 12 months. Likewise, the equity's SOIR of 0.95 registers in the 89th percentile of its annual range.
A short squeeze could add fuel to ImmunoGen, Inc.'s fire, though. Short interest accounts for 13.7% of the stock's total available float, representing nearly eight sessions' worth of pent-up buying demand, at the equity's average pace of trading.
On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures Act” (the “Act”) would foster significant regulatory changes in the introduction of new drugs to the market. The legislation passed 344-77 with strong, bipartisan support, though opponents raise concerns about the Act’s lack of assurances of patient safety.
The main focus of the 352-page Act is a reduction of bottlenecks in the regulatory process that, supporters claim, slow the development of new drugs. The Act would trim regulations by allowing for shorter clinical studies involving fewer individuals for certain kinds of drugs. It would also allow for expanded use of surrogate endpoints as evidence of the efficacy of drugs. Surrogate endpoints are biomarkers (such as blood pressure for hypertension), which are thought to predict clinical benefit, but are not outright measures of such benefit. Use of surrogate endpoints can significantly decrease the time of clinical trials. For example, instead of having to wait to learn if a drug actually extends survival for diabetic patients, the FDA could approve a drug based on evidence that it reduces hemoglobin A1C levels. The onus remains on drug makers to then prove that reductions in A1C levels lead to a longer lifespan.
If a drug that is already on the market is shown to have a new use, the Act will allow case studies to suffice as evidence of the new benefit rather than require additional clinical trials. The Act will also increase the use of patient registries and existing health care data to speed up clinical trials. These regulatory changes would be enhanced by a five-year, $8.75 billion increase in funding to the National Institutes of Health – a major financier of biomedical research in the U.S. The NIH would also host a new Cures Innovation Fund which would support breakthrough biomedical research. The Act would enhance funding to the FDA by $550 million.
Cantor Fitzgerald downgraded Immunogen Inc. (NASDAQ: IMGN) from Buy to Hold with a price target of $21.00 (from $12.00) on valuation.
Analyst Mara Goldstein commented, "We are downgrading ImmunoGen shares to HOLD from BUY, and raising our PT to $21 from $12. Our PT raise reflects greater value for IMGN853, about to enter Phase II, and the remainder of the pipeline. However, we feel that these assets are fairly well represented in our new valuation, and while the shares still have room to advance, the upside is less than what we typically like to see for BUY-rated biotechs. We think there is incremental upside to be had from the pipeline, but major inflection points are not likely, in our view, before 2H:CY16."
Barrron's says $52 would be the buy point!
Are you saying the FDA should ignore 53% response to an unmet medical need just because others have failed? Others have failed with immunotherapy targeting Car T in the past so should these new breakthrough therapies be eliminated as well? Don't let your short position get in the way of a much needed therapy to those suffering from platinum resistant ovarian cancer.
What's everyone think about earnings? ABBV Hep c revenue exceed expectations by $15million for the qtr however, the underlying scripts did not meet. Does this matter for ENTA? Barrons said the buy point for the stock was $51.00. We achieved that, so it should go higher. Data for ABT 493 should be coming out 2H 2015 as well as preclinical candidate selection for NASH. So will there be a short term pull back or will earnings exceed and drive greater momentum? Believe this stock is header higher and something big may be going on behind the seen as the buy interest has been very strong!
Looks More like accumulation with low liquidity. Not many sellers and a fund is trying to accumulate a sizable position. Getting ready for Japan approval, phase 3 of next 493, and moving a NASH candidate into phase 1
If we fall back it will bounce off of the 50 SMA and serve as buying opportunities, otherwise, onward and upward!
Million share buy block at $45 last minute of trading. I realize today is a triple witch but it is still very bullish!
This run-up has really been off the radar screen. Some major accumulation going on! Could ABBV be the quiet accumulator?
Only other reason would be because he's leaving company and would lose them. Either way it is positive!
Low liquidity. It had to pull back sometime, it's been on a meteroric rise. This is healthy for next move up. Luly sounded very positive and excited about what they have going on during the JPM conference